technology assessment andsupport oflife-sustaining …...pital-based hmv program, has served over...

1448 Technobgy and Assessment and Support of LJfe-sustainlng De�nces in Home Care (Allen I. Goklbeip)

Technology Assessment and Supportof Life-sustaining Devices in HomeCare*The Home Care Physician Perspective

Allen I. Goldberg, M.D., M.M., F.C.C.P.

Practicing physicians are increasingly using life-

sustaining devices in the home setting for patientswith long4erm needs due to chronic conditions. Atthe same time, public policy focus on technology assess�ment has broadened from narrow medical concernsabout safety and efficacy to considerations of effec-tiveness, quality of life, patient preferences, andcost/benefit. Around the world high-technology home

care (HTHC) features a number of ways to evaluateoutcomes. One category of HTHC that requiresinitial and on-going technology assessment is homemechanical ventilation (HMV). Home MV has devel-oped in nations with a variety of healthcare financesystems: England (national health system), France(national health insurance), and the United States

(regulated/market-economy). Approaches to tech-nology assessment differ among nations accordingto organizational design and evolution. Physicianbehavior is a major determinant in the applicationof medical technologies. There are new physicianroles that can influence what, when, and how tech-nology is appropriately used in the home-initially

and over time. For this reason, it is crucial toconsider the role of the practicing physician inhome care technology assessment.

(Chest 1994; 105:1448-58)

FDAFood and Drug Administration; HMVhomemechanical ventilation; HTHChigh-technology home

care

5 nations battle the rising burden of expendi-

tumes for heaithcame and social services, they

face new demands from growing numbers of people

with chronic conditions.’ This population sector in-

ciudes survivors of life-threatening illness of all ages

who have benefited from modern medical progress

in acute cane, some of whom depend on the pro-

longed use of life-sustaining technologies. More

efforts are needed to determine the size of the

segment requiring long-term cane.2 The transfer of

these patients from institutions to community alter-

native came settings may result in cost savings and

improved health outcomes.

The assessment of medical technology and its

relation to cost and quality management concerns

many groups: heaithcare professionals, engineers,

physical and social scientists, public policy analysts,

government officials, business coalitions, and con-

sumem organizations. These groups have broadened

the scope of technology assessment from concerns

about safety and efficacy to considerations of effec-

tiveness, quality of life, patient preference, and

cost/benefit. The application of new technologies

and overuse of existing ones account for up to 50

percent of the rise in healthcare costs.3’4

*From the Loyola University Medical Center, Stritch School ofMedicine, Loyola University of Chicago, Maywood, Illinois.

Manuscript received June 14, 1993; revision accepted Septem-ber 29.Reprint requests: Dr. Goldberg, Department of Pediatrics, Loy-ola University Medical Center, 2160 South First Avenue, May-wood, IL 60153

Many technologies are now applicable in the

home.5 Although home healthcare is not a new

concept,6 the use of life-sustaining technologies in

the home has a more recent history.7’8 It is essential

that groups concerned about technology assessment

have a better understanding of the home use of life-

sustaining devices. High-technology designed for

home use must be assessed before introduction and

reassessed with experience for efficacy and safety as

well as outcome and appropriateness.

The following observations review several na-

tions’ approaches to high-technology home care

(HTHC) in the form of home mechanical ventiia-

tion (HMV). They will consider the evolution of

programs from the poliomyelitis era to modern day

and focus on how each country has on has not

evaluated performance of devices used in the home.

They will attempt to determine if a systems ap-

proach is feasible, necessary, and whether it makes

a difference. They will describe technology assess-

ment for home came physicians-physicians who

consider the home as an appropriate setting for

care.

HISTORY OF HOME MECHANICAL VENTILATION

The poliomyelitis pandemic of the 1950s repme-

sented a global healthcare crisis affecting the lives

of countless children and young adults. The most

remembered achievement of that period was the

successful application of research leading to the

Downloaded From: http://journal.publications.chestnet.org/pdfaccess.ashx?url=/data/journals/chest/21694/ on 03/31/2017

CHEST/105/5/MAY,1994 1449

polio vaccine. The medical community, however,

also made major advances in life-supportive medical

technologies. For example, the prototype of the

modern positive pressure ventilator9 and its applica-

tion via tracheostomy reduced mortality due to

acute respiratory failure from 90 percent to 20

percent.10 A less-recognized technological advance

was the adaptation of mechanical ventilatons for

home use by physicians working with engineers and

polio survivors. These survivors with residual respi-

matory impairment required prolonged mechanical

assistance and desired to leave the institution and

return to their families. According to Gini Laurie,

Continuing home care was an integral part of the whole

system. . . . The centers and home care resulted intremendous financial savings and a greater degree ofindependence and self-sufficiency than was ever dreamed

possible for people so severely disabled. . . . The averagehospital time was cut from more than a year to sevenmonths. The home care costs were one-tenth to one-

fourth hospital costs.11

The poiiomyelitis experience represented the first

generation of ventilator-assisted individuals to use

HTHC. An international network of designated

polio respiratory centers arose, making technologi-

cal progress possible.’2 Physicians, engineers, and

manufacturers met and directly communicated their

needs and perspectives.13 Physicians played a vital

role with others in establishing a well-defined mecha-

nism for designing equipment, evaluating expeni-

ence, and tracking device performance.

After the poiiomyelitis era, the new technical

capabilities of long-term mechanical ventilation via

tnacheostomy provided the life-sustaining means to

maintain and improve the lives of patients with

other categories of chronic respiratory insufficiency.

Some physicians who had participated in interdisci-

plinary teams established to meet the complex needs

of polio patients became the first leaders of neona-

toiogy, critical care, and rehabilitation medicine. As

a result of advances in these modern interdiscipli-

nary practices, patients were saved with many van-

eties of previously fatal life-threatening medical and

surgical conditions. A few survivors who benefited

from this progress, however, still maintained a de-

gree of respiratory impairment that required pro-

longed support of medical technology.

The option of mechanical ventilation at home

currently exists in several nations.�16 In England,

France, and the United States, special centers omigi-

nally designated for polio provided the models for a

second experience in HMV. Critical cane and nespi-

matony rehabilitation units developed home cane

programs to permit the option of life in the commu-

nity for a new generation of ventilator-assisted

individuals. The organizational structure in each

nation reflected political, economic, social, and cul-

tural realities as determined by national, regional,

and local influences.’7’9 Each nation’s technological

achievements, product support, and device surveil-

lance mechanisms stemmed from the experiences,

perspectives, and backgrounds of the physicians

who helped design the home cane programs. The

architects of the original programs included physi-

cians from a variety of professional disciplines (le,neonatology, anesthesiology, critical care, pulmo-

nology, cardiology, surgery, rehabilitation medicine)

and other healthcare professionals (ie, nursing, mes-

piratony cane, social work, physical therapy).

Ventilator-assisted individuals do not always have

the same HMV option. Where they do, the quality

of their program and safety at home varies greatly by

location. Current life-sustaining technology used at

home also varies in terms of availability and penfon-

mance evaluation. In many situations where HMV

has been available for several decades, the original

technology initially designed for home or hospital

application is still in use. This technology has been

used for prolonged periods with or without assess-

ment oven time. Although the equipment may have

originally met patient needs, most early technolo-

gies predate the rigors of current device standards

and pnemarketing/clinical application approval pro-

cesses.

In general, devices are used either on an mdi-vidual or collective basis with variable tracking of

location, use record, repair experiences, and main-

tenance history. Older technologies are used inter-

changeably and/or modified. More modern prod-

ucts specifically designed and manufactured for

home use may have been subject to an initial

technology assessment. There have been few at-

tempts at reassessment, however, since there is no

formal system in place to make involved actors

aware of device failure or inadequacies during a

product life-cycle.5

Patient safety, quality determination, medical

necessity, cost control, and risk management de-

mand technology assessment to evaluate the medi-

cal appropriateness and performance of technology

after prolonged application in the home. The foi-

lowing remarks will show this need and update

previous communications about approaches to these

concerns in three nations where HMV has evolved

in different heaithcare finance systems: England

(national health system), France (national health

insurance), and the United States (market-on-

ented).’�2#{176}

MULTINATIONAL COMPARISON OF HOME

MECHANICAL VENTILATION

England

The “Responaut Program,” England’s unique hos-


1450 Technokgy and Assessment and Suppoil of Ufe-sustaining Devices in Home Care (Allen I. Goldberg)

pital-based HMV program, has served over 500

patients for more than 20 years.’5 As with most

regional HMV programs of this magnitude, it began

with the need to send home polio survivors with

chronic respiratory insufficiency. When these pa-

tients were incorporated into the first !CU in Eng-

land at St. Thomas Hospital, they considered them-

selves “Responauts,” risking to enter the “unknown”-

their community-despite prolonged need for me-

chanical ventilation. This program, based now in the

Baroness Lane Fox unit, continues to actively serve

about 250 persons at home. The majority of

Responauts have neuromuscular diseases and reside

with their families all over the United Kimgdom.

Those Responauts with complex medical needs and

no family members can benefit from HMV with cane

from personal attendants as a nsuit of recommen-

dations of the Responaut Study.2’

The devices used at home by the Responaut

Program include positive pressure “respirators” fea-

turing simple “bicycle technology” and “alligator”

iron lungs, which open to provide ready access and

permit notation for physical therapy. This innovative

technology, specially designed for the original polio

survivors, has a history of simplicity for instruction,

adaptability for use, proven reliability, and ease of

maintenance and repair.

Hospital-based technicians track the performance

of all original equipment. These experts make

monthly/bimonthly visits to the homes for routine

maintenance and surveillance of the well-being of

the Responauts, as well as emergency repair calls at

any time of day on night. They replace original

equipment with a loaner when they must perform

more extensive repair in the hospital-based work-

shop. In the past when modern devices were im-

ported, they were proven to be costlier to purchase

and maintain. Manufacturers of imported technol-

ogy had not established repair facilities in England,

and returning them abroad required one-third to

one-fourth the cost of the original machine and up

to 4 months (C. Spencer, personal communication,

1990)! Modern portable ventilators for home cane are

now manufactured in England. Examples include

The Nippy portable positive pressure ventilator

(Thomas Respiratory Systems, London, England)

and the Brompton PAC assiston-controiled ventilator

(Pneumo Pac, Luton Beds, England).

The Responaut Program is directed by an expert

home cane physician, who remains personally in-

volved in technology assessment for each patient.

All Responauts at home have direct telephone ac-

cess to the hospital base-unit and this physician.

Professional team members representing multiple

disciplines (ie, nursing, physical/respiratory therapy,

social work) schedule regular home visits to each

ventilator-user and their equipment. The physician

and team members always remain immediately avail-

able to support technical, medical, social, and finan-

cial needs. The physician communicates with manu-

factunems providing direct feedback regarding

equipment performance and design modification.

France

France has a system of 32 regional associations

and one national organization that serves over 20,000

ventilator-assisted and/on oxygen-dependent per-

sons. Its origin dates back to the 1960s when polio

patients were discharged from respiratory centers,

which had subsequently evolved into !CUs, to des-

ignated home care organizations in the commu-

nity.8’16 At the end of the 1970s, the French govern-

ment authorized a study evaluating the initial me-

gional experiences with home mechanical ventila-

tion?’�’� The study recommended a uniform national

approach for both home mechanical ventilation and

the growing demand for home oxygen. This resulted in

the establishment of associations for chronic respira-

tony insufficiency in all regions of France and the

creation of a national organization (Association Na-

tional pour la Tm#{225}itment aDomicile de l’insuffisance

Respiratoine, ANTAD!R).’82#{176}

Currently, HMV is available in every part of

France from designated, not-for-profit regional as-

sociations that provide equipment, supplies, clinical

oversight, and technological surveillance. The

patient’s physician must prescribe devices for home

use by a uniform national mechanism that guaran-

tees full reimbursement for the technology and its

essential support. After physicians from the regional

association and social security review each initial

prescription ANTAD!R orders the appropriate

equipment, which receives its own identification

number. These prescriptions and a computerized

database permit the system to track and evaluate the

application of technology at home and the penfom-

mance of devices from initial manufacture and

delivery through all clinical use until obsolescence.

Regional associations do not provide primary

caregivens; ventilator-assisted persons in France

require care from a highly committed family. When

events at home require supplemental caregivers,

professionals and personal attendants are available

on a limited basis from other organizations.’�’7

Home care physicians, along with nurses, respina-

tony/physical therapists, and technician specialists

from regional associations do make intermittent

home visits to ensure that equipment matches the

need of each user and to evaluate technology per-

fonmance. In most regional associations, clinical and

technical information immediately enters a comput-

enized database that permits national pooling of


CHEST I 105 I 5 I MAY, 1994 1451

information for review, analysis, and feedback to

users and manufacturers. The information network

provides physicians with access to instant notifica-

tion by all regional associations of technological

problems as discovered. An “info-alert” and/or tn-

monthly bulletin disseminate news about relevant

experiences and unusual occurrences. Additionally,

expert physicians and technicians from regional

associations shame this information and conduct

essential field trials and device me-evaluations at the

Medical-Technology Commission of ANTADIR24

United States

In the United States, technology assessment is

impeded by our complex system that has many gaps.

It is true that the Food and Drug Administration

(FDA) evaluates new respiratory came products be-

fore distribution. By FDA regulation, manufactur-

ems must test new devices to establish safe and

effective performance before release to consumers.

However, market channels among manufacturers,

distributors, professionals, and consumers break-

down thereafter. Theme is no established mecha-

nism for multidirectional flow of safety information

or use experience. Although the home cane physi-

cian may have access to device reporting processes

for life-threatening events,�’26 the fragmentation of

our complex system hampers dissemination of iso-

lated experiences of inadequate product penfom-

mance. This leaves the physician, the HMV team

members, and the ventilator user without a pmede-

termined way to shame their device experiences and

inform both manufacturers and distributors. For the

physician, this translates into isolation; the only way

to learn about shared device performance expeni-

ences is through informal and irregular networking.

The home care physician depends heavily on com-

munication from the ventilator user, family mem-

bems, and professionals in the home for information

about technology performance. Personal attendants

who may serve as acceptable alternate caregivers for

ventilator-assisted individuals may be another source

of observations for the physician.27’�

The means of promoting product improvement

through technology assessment and information ex-

change in our free market has been limited. In the

past, funding for home care technology and its

support has been discretionary and dependent on

fragmented heaithcame funding policies. Managed

care organizations, commercial insurers, public pay-

ens, and self-insured employers have differed in

their willingness to pay for such coverage. A grow-

ing number of patients have had either insufficient

on nonexistent means to pay for technology sumveil-

lance. Only recently (1993) have Health Came Fi-

nancing Administration rulings defined comprehen-

sive home care requirements for health maintenance

organizations and managed came organizations based

on medical necessity without regard to cost or

duration. As a result of past funding inadequacies,

HTHC in the United States has featured inequities

of access and allocation of resources. Without suffi-

cient funding for technology and its support, the

physician and management team cannot adequately

address quality improvement, risk management, and

cost control.

Recent initiatives have begun to raise conscious-

ness about the need to disseminate information

about home care technology. In 1986, the American

College of Chest Physicians created guidelines for

physicians about mechanical ventilation in the home

or alternative community settings.28 In 1988, con-

sensus conferences sponsored by The American

Thonacic Society, The Food and Drug Administra-

tion, The American Association of Respiratory Came,

and The Health Resources and Services Administra-

tion addressed HMV and equipment-related prob-

lems.293#{176} Several committees of the American Soci-

ety for Testing and Materials developed voluntary

consensus standards,3’ and the Joint Commission of

Accreditation of Healthcare Organizations estab-

lished quality management accreditation for home

cane organizations providing support services me-

lated to medical technology.32 Consumer organiza-

tions have begun to formalize their networks to

share information,33 and manufacturers have estab-

lished networks among professionals to describe

product-related experiences.34 The National Center

for Home Mechanical Ventilation, an independent

nonprofit research organization supported by manu-

facturems, suppliers, healthcame professional associa-

tions and consumer organizations, encourages de-

vice performance tracking and information exchange

among representatives of its constituency.33 These

recent attempts, however, have not completely solved

the systemic fragmentation of technology assess-

ment and information dissemination.

DiscUssIoN AND RECOMMENDATIONS

Home care technology use and assessment in

England, France, and the United States show what

can (or cannot) be accomplished in different nations

because of (or despite) certain healthcare financial

and delivery systems in place. In each country,

healthcare professionals, consumers, and organiza-

tional leaders have achieved some awareness of the

universal importance of a mechanism to evaluate

and improve technology performance with use over

time.

In England, The Responaut Program represents a

unique model approach; it does not reflect a uni-

form national experience.36 Rather, it functions as a


1452 TechnolOgy and Assessment and Support of Life-sustaining Devices in Home Care (Alien I. Goldberg)

regional program with a national outreach. This

achieves technology assessment on a program level

without a formal system and despite healthcane

finance not necessarily geared for this purpose.

The French system shows a formal mechanism

established to track and reassess home technology

performance. Prior to application, a rigorous

premanket evaluation process with strict device stan-

dards and protocols determines acceptability of

technology for home use. The French system then

determines whether continuous home use is appro-

pniate, safe, and medically necessary. This mecha-

nism conforms to healthcare financing and political,

social, and cultural realities in France.19

The current inadequacy of technology tracking in

the United States results from absence of a defined

health policy and lack of success establishing an

organized way to effectively link all involved actors.

This is partly explained by our political history and

market based approach to the economy which en-

courages individual freedom, pluralism, and diver-

sity as an acceptable way we approach issues.20

Rather than working together for a common pun-

pose, professionals, service providers, manufactun-

ems, suppliers, and consumers have pursued and

lobbied their own interests. Our nation, however,

also has a tradition of unity of purpose and action in

times of crisis as shown during the poliomyelitis era.

Now is such a crisis due to the impact of technology

costs on overall heaithcare spending. Technology

assessment should involve all potential stakeholdens

of a system; they should also define the coordinated

way to accomplish it.14 The absence of an effective

systems approach will result in continued opera-

tional inefficiencies and requirements for additional

costly safeguards (second ventilatons, professional

surveillance). Consequently, HTHC may become

prohibitive for financial and risk concerns.

In the United States, there is a growing general

interest in technology assessment to accomplish

quality healthcane and cost containment.37 Evaiua-

tions of the Office of Technology Assessment found

that only a minority (15 to 20 percent) of existing

healthcare practices in 1978 were considered ben-

eficial based on well-controlled trials.38 Theme is a

strong case for regular reassessment of existing

technology in use as well as the assessment of newer

technology before introduction into the clinical

setting and heaithcane marketplace.5 Reassessment

is especially important in view of high economic

costs, burdens to patients and families, and risk of

adverse outcomes to users of technology that may

be inappropriately prescribed or continually used.

The scope of future technology assessment must

be broad. Devices and procedures should be cniti-

cally tested before routine clinical use, with the

focus going beyond the biomedical perspective of

safety and efficacy.39 The “new technology assess-

ment” has to include a wide scope of perspectives

representing multiple disciplines with an emphasis

on outcome, efficiency, and medical appropriate-

ness.L�� The interplay of forces that determine the

diffusion of technology in the marketplace is poorly

understood.5 Physician attitude and behavior, how-

even, determine to a large extent when and how

technology will be applied in the clinical setting.5

Unfortunately, not much is known about the influ-

ences on physicians regarding how they obtain and

apply practice-related information about use of tech-

noiogies.”#{176}

In the United States, HTHC may evolve without

input of physicians due to the lack of incentives for

physician participation.4’ Nevertheless, pediatric

home care physicians surveyed unanimously agree

that a physician must be directly involved.42 These

physicians stated a need for access to information

about home came technology to assume their respon-

sibilities. Physicians also want mechanisms to report

experiences as users of technology in the home.

These experiences would provide invaluable infor-

mation for technology reassessment.

A system that encourages physician participation

in home cane technology assessment should focus on

what physicians value: quality cane. Continuous

quality improvement activities of practicing physi-

cians should incorporate technology assessment. A

system also ought to reflect how physicians work; a

technology tracking mechanism should relate physi-

cians to physicians and to other healthcame profes-

sional experts. Physicians who use home cane tech-

nology have insights that might then be transmitted

to others involved in technology assessment and

technology tracking systems could integrate their

experiences.

The United States can look to other nations that

have created successful mechanisms for home care

technology assessment. The experiences of these

nations show that methods of technology evaluation

exist regardless of the healthcane finance system in

place. Each nation’s particular approach reflects

their own culture, which determines what and how

things are done. Physicians in each country recog-

nize that technology assessment represents a com-

ponent of quality, risk, and cost management that

impacts patient care and safety. Technology assess-

ment should incorporate physician experience as

technology users in the home environment.

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